Job Title:
QA Manager
Job ID:
R-209217
Location:
India – Hyderabad
Work Location Type:
On Site
Date Posted:
March 4, 2025
Category:
Quality
About the Company:
Amgen is a leading biotechnology company that has been at the forefront of innovation since 1980. With a mission to serve patients suffering from serious illnesses, Amgen focuses on four key therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Through research, manufacturing, and delivery of innovative medicines, Amgen aims to help people live longer, fuller, and healthier lives.
Role Overview:
The QA Manager will be responsible for overseeing quality assurance activities at the Amgen Technology and Innovation Center in Hyderabad. The role involves managing a team of quality professionals and collaborating with internal global teams as well as external contract manufacturing organizations to ensure the production and supply of high-quality products.
Key Responsibilities:
Manage a team of approximately six staff, ensuring structured, compliant task execution
Ensure team members are trained and qualified per company standards
Conduct performance reviews, goal-setting, and compensation planning
Implement and maintain quality records in line with GMP and regulatory requirements
Identify and drive process improvements using lean principles and automation
Track and report quality metrics to senior leadership
Collaborate cross-functionally to ensure seamless process transitions
Prepare, review, and approve SOPs and GMP/GDP documentation
May require shift work or extended hours to accommodate global time zones
Qualifications:
Educational Background (one of the following):
Doctorate degree, or
Master’s degree with 4–6 years of experience in quality management systems or a related field, or
Bachelor’s degree with 6–8 years of experience, or
Diploma with 10–12 years of experience
Additional Requirement:
Experience managing staff in a GXP environment
Required Skills:
Must-Have:
Minimum of 6 years’ experience in a cGMP manufacturing environment
Strong foundation in quality assurance practices
Proven leadership and team management skills
In-depth understanding of regulatory expectations
Ability to influence and inspire others
Good-to-Have:
Experience in investigations, project management, and data analysis
Supplier management, raw materials, packaging, or device manufacturing experience
Knowledge of API, drug substance, drug product, packaging, and device manufacturing
Process design or improvement at a conceptual level
Understanding of robust QMS and documentation standards
Soft Skills:
Excellent analytical and problem-solving capabilities
Strong written and verbal communication
Ability to work in global, virtual teams
Self-motivated and organized
Strong public speaking and presentation skills
Team-oriented mindset
What to Expect from Amgen:
Competitive benefits and career development opportunities
Collaborative and innovation-driven culture
Supportive environment for both professional and personal growth
Inclusive workplace committed to advancing science and improving lives
Application:
Apply now at careers.amgen.com for a career that defies imagination.
Amgen is an Equal Opportunity Employer and is committed to providing reasonable accommodations during the recruitment process for individuals with disabilities..
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